Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A small, lightweight and portable sy
FDA device recall Z-1018-2009 · posted 2009-03-09 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump inoperable or the Pump may not respond to certain keypad button presses.
- Action taken
- Consignees were initially notified of the recall via a telephone conversation beginning December 18, 2008 and continued through January 2009. After the initial telephone contact, an "Urgent Medical Device Recall" letter dated December 22, 2008 was sent via electronic mail. The letter was addressed to "Affiliates, Distributors, Clinicians, and other Customers". The letter gave a Description of the Problem and Advise on Action to be Taken by the User. Direct questions to Smiths Medical Customer Service department at 1-800-426-2448 (option 1, then option 3). A Smiths Medical Customer Service Representative will have contacted customers. These pumps will be fitted with new keypads with gold connectors. A second Smiths Medical "Urgent Medical Device Recall Additional Affected Units"recall letter was sent after the recall was expanded. The second letter dated March 6, 2009 was addressed to Safety/Risk Mangers, Healthcare Providers, Biomedical Engineers, Distributors, Clinicians and other Customers. The letter listed the Details of Affected Devices, Description of the Problem, Advise on Action to be Taken by the User, Results of Investigation and Contact Details.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 957
- Distribution
- Worldwide, including USA, AMERICAN SAMOA, AUSTRALIA, CANADA, CHILE, GERMANY, UNITED KINGDOM, HONG KONG, IRELAND, ISRAEL, SOUTH KOREA, NETHERLANDS, SAUDI ARABIA, SWEDEN
- Date initiated
- 2008-12-18
- Date posted
- 2009-03-09
- Date terminated
- 2012-07-06
- Location
- Saint Paul, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (K040899) | Medex, Inc. | 2004-04-30 |